Adult volunteers were skin tested with 1.27 ug spherule-derived coccidioidin. The skin test antigen was evaluated in three different populations of adult volunteers to determine the safety and efficacy of the product in the assessment of delayed-type hypersensitivity to Coccidioides immitis. Induration greater than or equal to 5 mm after 48 hours was considered positive for exposure to C. immitis.

To determine the ability of spherule-derived coccidioidin to detect cellular hypersensitivity to C. immitis by a positive DTH skin test in a population with a history of pulmonary coccidioidomycosis. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determine the specificity of spherule-derived coccidioidin by testing the skin test antigen in naive adult volunteer and volunteers with a history of pulmonary histoplasmosis. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Volunteers with a history of pulmonary coccidioidomycosis verified by serology and/or histology or mycology.

Biological: Spherule-derived coccidioidin

1.27 ug of sterile, injectable product (spherule-derived coccidioidin). Product was administered once by intradermal injection along with positive and negative control agents and results read after 48 hours.

Other Name: Coccidioidin SD (proposed trade name)

Active Comparator: 2

Volunteers without a history of pulmonary coccidioidomycosis confirmed by serology (naive).

Biological: Spherule-derived coccidioidin

1.27 ug of sterile, injectable product (spherule-derived coccidioidin). Product was administered once by intradermal injection along with positive and negative control agents and results read after 48 hours.

Other Name: Coccidioidin SD (proposed trade name)

Active Comparator: 3

Volunteers with a history of pulmonary histoplasmosis but no history of coccidioidomycosis confirmed by serology.

Biological: Spherule-derived coccidioidin

1.27 ug of sterile, injectable product (spherule-derived coccidioidin). Product was administered once by intradermal injection along with positive and negative control agents and results read after 48 hours.

Other Name: Coccidioidin SD (proposed trade name)

Eligibility

Ages Eligible for Study:

18 Years to 65 Years (Adult)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Good Health (absence of active medical disease)

Meets criteria specific to population groups:

Coccidioidomycosis Group:

History of coccidioidomycosis of at least 45 days duration confirmed by roentgenograph serologic or mycologic findings

Current treatment with corticosteroids, cytotoxic or immunosuppressive drugs

Immunodeficiency disease

HIV infection

Previous skin test with coccidioidin or SD Coccidioidin

Pregnant or lactating

Adverse reaction to thimerosal

Adverse reaction to Candida or Trichophyton skin test antigens

Coccidioidomycosis Group:

Current cavitary or disseminated coccidioidomycosis

History of histoplasmosis, or blastomycosis

Histoplasmosis Group:

History of coccidioidomycosis or blastomycosis

Naive Control Group:

History of coccidioidomycosis, histoplasmosis, blastomycosis

Travel for more than 30 days in designated areas of CA, AZ, NV, UT, NM, TX and Mexico, Central and South America. Travel for more than 7 days in restricted areas of CA, AZ and TX.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690092